(78 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Blue & White Colour Powder Free Barrier Pro™ Polybutadiene Copolymer Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00a563 Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from BarrierPro™ synthetic copolymer rubber latex, a polybutadiene based copolymer. They are blue in colour and are powder free.
The provided document describes the acceptance criteria and performance of Non-Sterile Blue & White Colour Powder Free Barrier Pro™ Polybutadiene Copolymer Examination Gloves. This device is a medical glove, not an AI/ML powered medical device, and therefore the acceptance criteria and study detailed below are for the physical and chemical properties of the gloves, not an algorithm's performance.
Here's the information based on the provided text, formatted to your request where applicable:
1. Table of Acceptance Criteria and the Reported Device Performance
| TEST | ASTM D6319-00a3 (Acceptance Criteria) | POWDER FREE BARRIER PROTM EXAM. GLOVES (Reported Device Performance) |
|---|---|---|
| 1. Watertight (1000ml) | Multiple Normal GI AQL = 2.5 | Pass GI AQL = 2.5 |
| 2. Length (mm) | 240 mm minimum for all sizes | |
| Size XS | Min 220 | |
| Size S | Min 220 | |
| Size M | Min 230 | |
| Size L | Min 230 | |
| Size XL | - | |
| 3. Palm width (mm) | ||
| Size XS | $70 \pm 10$ | 73 - 78 |
| Size S | $80 \pm 10$ | 83 - 88 |
| Size M | $95 \pm 10$ | 93 - 98 |
| Size L | $111 \pm 10$ | 103 - 107 |
| Size XL | - | |
| 4. Thickness (mm) (Single Layer) | ||
| Finger | Min 0.05 | Min 0.08 |
| Palm | Min 0.05 | Min 0.08 |
| 5. Physical Properties | ||
| Before Aging | ||
| - Tensile Strength (MPa) | Min 14 | 17-21 |
| - Ultimate Elongation (%) | Min 500 | 630 - 710 |
| After Aging | ||
| - Tensile Strength (MPa) | Min 14 | 16-20 |
| - Ultimate Elongation (%) | Min 400 | 610-670 |
| 6. Powder Content | Max 2.0mg/glove (FDA Requirement quoted below table) | Below 2 mg/glove |
In addition, the device successfully passed the Bio-compatibility Test, which included a Primary Dermal Irritation Test and a Guinea Pig Sensitization (Buehler) test.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the test set for each of the physical property tests. The data provenance is also not specified beyond the fact that the manufacturer is YTY Industry (Manjung) Sdn Bhd (Malaysia). There is no indication whether the testing was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the "ground truth" here refers to objective physical and chemical properties measured according to established ASTM standards, not subjective interpretations by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as the testing involves objective measurements against predefined standards (ASTM D6319-00a3 and FDA watertight test for physical properties, and bio-compatibility tests) and does not involve human adjudication for "ground truth".
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable as the device is a medical glove, not an AI/ML powered medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a medical glove, not an AI/ML powered medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on established industry standards and objective measurements. Specifically:
- ASTM D6319-00a3 Standard Specification for Nitrile Examination Gloves for Medical Application for physical properties (e.g., length, width, thickness, tensile strength, elongation).
- FDA 1000ML watertight test for barrier integrity.
- Bio-compatibility tests (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test) for biological safety.
8. The sample size for the training set
This question is not applicable as the device is a medical glove, not an AI/ML powered medical device that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable as the device is a medical glove, not an AI/ML powered medical device that requires a training set.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.